Development and testing of AIDS vaccines are high priorities for NIH-supported research (NOT-OD-15-137).
This Funding Opportunity Announcement (FOA) invites applications from qualified academic institutions to apply for support to upgrade existing functioning space to Current Good Manufacturing
Practice (CGMP) standards for production of next generation candidates for HIV/AIDS vaccines, with the goal of creating sufficient quantities of immunogens to conduct Phase I clinical trials.
The applicants should:
a) demonstrate the highest level of expertise in HIV/AIDS biology and have experience in development and testing of concepts for AIDS vaccines; b) have vaccine candidates that have been produced in pre-clinical lots and tested for immunogenicity in appropriate animal models; c) have vaccine candidates that can be scaled up from pre-clinical lots to CGMP standards for Phase I clinical trials; d) have the capability and analytics expertise to conduct process development, and scale-up production of pharmaceutical quality compounds to clinical trials-levels, and e) have the ability to implement Phase I clinical trials.
In parallel, the applicants should demonstrate the highest level of skill and competency in all technical aspect of the design, construction, and commissioning of the facility, to ensure that relevant Federal and Industry standards are met for production of pharmaceutical grade compounds.